OncoMatch/Clinical Trials/NCT06469008
A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Is NCT06469008 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-B16D1 for head and neck squamous cell carcinomas.
Treatment: BL-B16D1 — This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of BL-B16D1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
who failed or could not receive standard treatment
Cannot have received: antineoplastic therapy
Antineoplastic therapy within 4 weeks or 5 half-lives before the first dose
Cannot have received: mitomycin (mitomycin)
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: nitrosoureas (nitrosoureas)
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: oral drugs such as fluorouracil (fluorouracil)
Oral drugs such as fluorouracil
Cannot have received: anthracycline-based adjuvant therapy
Exception: cumulative dose anthracycline-based drugs > 360 mg/m2
Previous anthracycline-based adjuvant therapy (new), the cumulative dose anthracycline-based drugs > 360 mg/m2
Lab requirements
Blood counts
The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening
Cardiac function
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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